EP1399111B1 - Injizierbare sterile zusammensetzung als schönheits- und/oder korrekturzweck - Google Patents
Injizierbare sterile zusammensetzung als schönheits- und/oder korrekturzweck Download PDFInfo
- Publication number
- EP1399111B1 EP1399111B1 EP02748952A EP02748952A EP1399111B1 EP 1399111 B1 EP1399111 B1 EP 1399111B1 EP 02748952 A EP02748952 A EP 02748952A EP 02748952 A EP02748952 A EP 02748952A EP 1399111 B1 EP1399111 B1 EP 1399111B1
- Authority
- EP
- European Patent Office
- Prior art keywords
- composition
- composition according
- dye
- skin
- vector
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired - Lifetime
Links
- 239000007972 injectable composition Substances 0.000 title claims abstract description 5
- 239000000203 mixture Substances 0.000 claims abstract description 44
- 239000013598 vector Substances 0.000 claims abstract description 14
- 238000007920 subcutaneous administration Methods 0.000 claims abstract description 7
- 238000009792 diffusion process Methods 0.000 claims abstract description 3
- 210000003491 skin Anatomy 0.000 claims description 26
- 238000002347 injection Methods 0.000 claims description 20
- 239000007924 injection Substances 0.000 claims description 20
- 239000000975 dye Substances 0.000 claims description 17
- 238000000034 method Methods 0.000 claims description 12
- 210000003462 vein Anatomy 0.000 claims description 10
- 229920002674 hyaluronan Polymers 0.000 claims description 6
- KIUKXJAPPMFGSW-DNGZLQJQSA-N (2S,3S,4S,5R,6R)-6-[(2S,3R,4R,5S,6R)-3-Acetamido-2-[(2S,3S,4R,5R,6R)-6-[(2R,3R,4R,5S,6R)-3-acetamido-2,5-dihydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-2-carboxy-4,5-dihydroxyoxan-3-yl]oxy-5-hydroxy-6-(hydroxymethyl)oxan-4-yl]oxy-3,4,5-trihydroxyoxane-2-carboxylic acid Chemical compound CC(=O)N[C@H]1[C@H](O)O[C@H](CO)[C@@H](O)[C@@H]1O[C@H]1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@@H]([C@@H](O[C@H]3[C@@H]([C@@H](O)[C@H](O)[C@H](O3)C(O)=O)O)[C@H](O)[C@@H](CO)O2)NC(C)=O)[C@@H](C(O)=O)O1 KIUKXJAPPMFGSW-DNGZLQJQSA-N 0.000 claims description 5
- 229960003160 hyaluronic acid Drugs 0.000 claims description 5
- 210000002615 epidermis Anatomy 0.000 claims description 4
- 231100000241 scar Toxicity 0.000 claims description 4
- 102000008186 Collagen Human genes 0.000 claims description 3
- 108010035532 Collagen Proteins 0.000 claims description 3
- 229920001436 collagen Polymers 0.000 claims description 3
- 206010040825 Skin depigmentation Diseases 0.000 claims description 2
- 238000004519 manufacturing process Methods 0.000 claims description 2
- 229920001296 polysiloxane Polymers 0.000 claims description 2
- 230000000873 masking effect Effects 0.000 claims 1
- 238000013508 migration Methods 0.000 claims 1
- 230000005012 migration Effects 0.000 claims 1
- 239000003086 colorant Substances 0.000 abstract description 5
- 210000004207 dermis Anatomy 0.000 description 3
- 239000000499 gel Substances 0.000 description 3
- 238000002360 preparation method Methods 0.000 description 3
- 238000004040 coloring Methods 0.000 description 2
- 238000010790 dilution Methods 0.000 description 2
- 239000012895 dilution Substances 0.000 description 2
- 208000032544 Cicatrix Diseases 0.000 description 1
- 208000012641 Pigmentation disease Diseases 0.000 description 1
- 230000005856 abnormality Effects 0.000 description 1
- 239000003708 ampul Substances 0.000 description 1
- 239000002537 cosmetic Substances 0.000 description 1
- 238000002316 cosmetic surgery Methods 0.000 description 1
- 230000001419 dependent effect Effects 0.000 description 1
- 230000035614 depigmentation Effects 0.000 description 1
- 230000008034 disappearance Effects 0.000 description 1
- 238000004043 dyeing Methods 0.000 description 1
- 210000000744 eyelid Anatomy 0.000 description 1
- 239000012530 fluid Substances 0.000 description 1
- 230000019612 pigmentation Effects 0.000 description 1
- 230000005855 radiation Effects 0.000 description 1
- 238000002278 reconstructive surgery Methods 0.000 description 1
- 230000037387 scars Effects 0.000 description 1
- 230000037075 skin appearance Effects 0.000 description 1
- 239000002904 solvent Substances 0.000 description 1
- 230000001954 sterilising effect Effects 0.000 description 1
- 238000004659 sterilization and disinfection Methods 0.000 description 1
- 230000037303 wrinkles Effects 0.000 description 1
Images
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/52—Hydrogels or hydrocolloids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/06—Flowable or injectable implant compositions
Definitions
- the invention relates to a novel injectable sterile composition for esthetic and / or restorative purposes and to the use of a mixing apparatus for preparing said composition. It is also intended for use in a method of aesthetic and / or restorative treatment.
- the skin often has many imperfections such as spots, depigmentations, vein marks visible through the skin, deep circles, scars ... These differences in color, these pigmentation abnormalities are often considered unsightly.
- the daily practice of cosmetic and reconstructive surgery has allowed the inventor to see a growing demand for this type of restorative intervention. Until today, this demand was not satisfied, for lack of appropriate means to compensate for problems of color differences of the skin.
- the object of the invention is therefore to provide a sterile injectable composition capable of restoring the desired aesthetic to the skin. It also proposes the use of a mixing apparatus making it possible to manufacture said composition.
- the sterile injectable composition for aesthetic and / or restorative purposes is characterized in that it comprises, in an effective amount, at least one colorant of suitable color and a biocompatible vector making it possible to control the diffusion of said dye, during Subcutaneous, subdermal injection and / or intra-dermal of said composition, precisely on the area to be treated.
- a biocompatible vector is any vector that can be injected, without danger to health, into a part of the human body, and which is tolerated by it.
- the vector of such a composition comprises at least one gel, preferably bioresorbable, allowing the dye not to migrate.
- This gel is preferably chosen from the group comprising a hyaluronic acid and / or a collagen.
- An example of a suitable nonabsorbable vector is given by silicone.
- Such gels, resorbable or not, are introduced into the composition in sufficient quantity to give the composition a sufficient viscosity to leave in place the internal makeup, once the injection is made. Indeed, the more the composition is viscous, the more precise its location will be. On the other hand, too much viscosity can induce deformation of the skin.
- the dye of this composition is chosen according to the complexion of the skin to be treated. Its hue is identical to that of the skin. It is preferable to play on the dilution of the dye in the composition to define the intensity of the coloring. To be usable for injection purposes, the dye must have health safety guarantees.
- the proportion of dye to be introduced into the composition according to the invention varies according to the degree of transparency of the skin of the subject to be treated. In general, the clearer the skin, the greater the dilution.
- composition of the invention is sterile because it is intended to be injected subcutaneously, subdermally and / or intradermally to form a screen under the dermis, under the epidermis and / or in the dermis.
- the invention also proposes the use of a mixing apparatus capable of preparing the dye of the composition according to the invention after analysis of the coloration of the skin of the subject to be treated.
- the apparatus used comprises a colorimeter to reconstitute a specific shade, from a range of dyes, by mixing them, in proportions calculated by the mixing apparatus.
- the apparatus used may, on the other hand, advantageously combine a colorimeter and a viscometer so as to prepare the composition according to the invention extemporaneously.
- the choice of the vector and the final viscosity of the composition is defined by the practitioner according to the parameters mentioned above.
- the apparatus can then, based on these data, make a composition having the desired hue and viscosity.
- the use of the apparatus according to the invention can be sterile so that the prepared composition can be used immediately.
- the invention also aims at providing a method of aesthetic treatment by internal makeup of the skin, characterized in that a subcutaneous, subdermal and / or intradermal injection of the composition according to the invention is carried out in order to create an opaque screen localized while leaving intact the transparency of the upper layers of the epidermis.
- the choice of the type of injection depends on the fineness of the skin to be treated.
- an intra-dermal injection is used for the makeup of a scar, whereas the makeup of a ring is performed by a subdermal injection.
- the injection is therefore performed at a given depth, dependent on the area to be treated, the thickness and the transparency of the skin.
- the quantity of product to be injected as well as the number of injections depend on the extent of the area to be treated and its location on the body.
- the advantage of such a method is to be able to correct imperfections of the skin in transparency.
- the injections are localized in depth, by subcutaneous, subdermal and / or intradermal lapping of the area to be treated with the aid of the composition, the transparent appearance of the upper layers of the epidermis is preserved. This method makes it possible to obtain a very natural result.
- such a method can illuminate or darken a specific skin area. It also makes it possible to mask the darkness of dark circles by subdermal dyeing, to recolor depigmentation spots or to mask veins.
- veins near the surface of the skin to show a blue mark on it.
- the injection of the composition between the surface of the skin and the vein forms a kind of colored and opaque screen making disappear such marks.
- This method finally makes it possible to make up a scar having an unsightly appearance due to a problem of coloring.
- FIG. 1 illustrates the makeup of an apparent vein with the invention.
- Example 1 deep opacification of the skin to remove a vein mark in a fair skinned subject.
- the injection is therefore performed subdermally.
- the amount injected is about 1 cm 3 .
- the injection is made in a single puncture, the needle being movable to distribute the product (how to operate identical to that used to repair wrinkles).
- Figures 1A and 1C show the location of the vein on the subject's arm, before the injection (1A) and three months after the injection (1C). We can see the disappearance of the mark of the vein. It should be noted that the hue of the composition used blends well into the skin tone of the subject.
- Figure 1B illustrates the injection of the composition.
- Example 2 Use of the mixer device.
- the mixing apparatus comprises a colorimeter. At first, it is calibrated using a range of skin colors. Such a range is commercially available.
- the dye is then mixed with the vector and a suitable solvent.
- the viscometer controls the respect of the data.
- the composition is delivered in an ampoule after sterilization.
- a simplified version of the mixing apparatus has a choice of hyaluronic acids at predefined viscosities. It is then sufficient to choose the type of hyaluronic acid to mix in the composition.
Landscapes
- Health & Medical Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- Medicinal Chemistry (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Transplantation (AREA)
- Epidemiology (AREA)
- Veterinary Medicine (AREA)
- Dermatology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Dispersion Chemistry (AREA)
- Medicinal Preparation (AREA)
- Cosmetics (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Infusion, Injection, And Reservoir Apparatuses (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
Claims (11)
- Injizierbare sterile Zusammensetzung zu ästhetischen und/oder Ausbesserungszwecken, dadurch gekennzeichnet, dass sie in wirksamer Menge mindestens einen opaken Farbstoff mit einem Farbton, welcher mit demjenigen der zu behandelnden Haut identisch ist, und einen biokompatiblen Vektor aufweist, der das Kontrollieren der Diffusion des Farbstoffs bei der Injektion durch subkutanes, subdermales und/oder intradermales Auftragen der Zusammensetzung genau auf die zu behandelnde Zone ermöglicht.
- Zusammensetzung nach Anspruch 1, dadurch gekennzeichnet, dass der Vektor mindestens ein Gel, vorzugsweise ein biologisch resorbierbares Gel, aufweist, welches das Wandern des Farbstoffs verhindert.
- Zusammensetzung nach Anspruch 2, dadurch gekennzeichnet, dass das Gel aus der Gruppe gewählt ist, die aus einer Hyaluronsäure, einem Kollagen und/oder einem Silikon besteht.
- Zusammensetzung nach einem der Ansprüche 1 bis 3, dadurch gekennzeichnet, dass der Vektor in ausreichender Menge in die Zusammensetzung eingebracht ist, um dieser eine Viskosität zu vermitteln, welche es dieser ermöglicht, an ihrer Position zu verbleiben, ohne die behandelte Zone zu verformen.
- Verwendung eines Kolorimeters/Mischers zur sofortigen Herstellung des Farbstoffs der Zusammensetzung nach einem der Ansprüche 1 bis 4, ausgehend von einer Farbstoffpalette, dadurch gekennzeichnet, dass das Kolorimeter mit einem Viskosimeter kombiniert ist, wodurch die unmittelbare Herstellung der Mischung aus Vektor und Farbstoff der Zusammensetzung nach einem der Ansprüche 1 bis 4 möglich ist.
- Verwendung nach Anspruch 5, dadurch gekennzeichnet, dass sie die sterile Herstellung der Zusammensetzung der Ansprüche 1 bis 4 ermöglicht.
- Verfahren zur ästhetischen und/oder Ausbesserungsbehandlung durch inneres Kaschieren, dadurch gekennzeichnet, dass die Zusammensetzung nach einem der Ansprüche 1 bis 4 subkutan, subdermal und/oder intradermal injiziert wird, um eine lokale opake Abdeckung zu erzeugen, wobei gleichzeitig die Transparenz der oberen Schichten der Epidermis unbeschadet bleibt.
- Verfahren nach Anspruch 7 zum Korrigieren von Transparenzzonen der Haut.
- Verfahren nach Anspruch 7, das ein Aufhellen oder Abdunkeln einer bestimmten Hautzone ermöglicht.
- Verfahren nach Anspruch 7 zum Abdecken von Augenringen, Venen und/oder depigmentierter Flecken.
- Verfahren nach Anspruch 7 zum Kaschieren einer Narbe.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
FR0107981A FR2825924B1 (fr) | 2001-06-18 | 2001-06-18 | Composition sterile injectable a visee esthetique et/ou reparatrice |
FR0107981 | 2001-06-18 | ||
PCT/FR2002/002033 WO2002102328A1 (fr) | 2001-06-18 | 2002-06-13 | Composition sterile injectable a visee esthetique et/ou reparatrice |
Publications (2)
Publication Number | Publication Date |
---|---|
EP1399111A1 EP1399111A1 (de) | 2004-03-24 |
EP1399111B1 true EP1399111B1 (de) | 2007-02-14 |
Family
ID=8864454
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP02748952A Expired - Lifetime EP1399111B1 (de) | 2001-06-18 | 2002-06-13 | Injizierbare sterile zusammensetzung als schönheits- und/oder korrekturzweck |
Country Status (8)
Country | Link |
---|---|
EP (1) | EP1399111B1 (de) |
AT (1) | ATE353624T1 (de) |
DE (1) | DE60218157T2 (de) |
DK (1) | DK1399111T3 (de) |
ES (1) | ES2281530T3 (de) |
FR (1) | FR2825924B1 (de) |
PT (1) | PT1399111E (de) |
WO (1) | WO2002102328A1 (de) |
Cited By (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
DE102011119729A1 (de) | 2011-11-30 | 2013-06-06 | S & V Technologies Ag | Polymerisierbare Farbstoffe und deren Zusammensetzungen für opthalmologische Anwendungen |
US9144631B2 (en) | 2003-01-27 | 2015-09-29 | Benedicte Asius | Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof |
Families Citing this family (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPWO2005117995A1 (ja) * | 2004-06-03 | 2008-04-03 | 丈二 北山 | ヒアルロン酸のセンチネルリンパ節同定への応用 |
CN105769603A (zh) * | 2016-03-02 | 2016-07-20 | 陈思敏 | 一种微注粉底及其制备方法 |
Family Cites Families (2)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JP2774695B2 (ja) * | 1991-03-29 | 1998-07-09 | コラーゲン コーポレイション | 顔のしわを処置する装置および方法 |
WO2000051553A1 (en) * | 1999-03-01 | 2000-09-08 | The General Hospital Corporation | An anti-reflective cosmetic composition for reducing the visibility of wrinkles |
-
2001
- 2001-06-18 FR FR0107981A patent/FR2825924B1/fr not_active Expired - Fee Related
-
2002
- 2002-06-13 DE DE60218157T patent/DE60218157T2/de not_active Expired - Lifetime
- 2002-06-13 AT AT02748952T patent/ATE353624T1/de not_active IP Right Cessation
- 2002-06-13 DK DK02748952T patent/DK1399111T3/da active
- 2002-06-13 PT PT02748952T patent/PT1399111E/pt unknown
- 2002-06-13 WO PCT/FR2002/002033 patent/WO2002102328A1/fr active IP Right Grant
- 2002-06-13 EP EP02748952A patent/EP1399111B1/de not_active Expired - Lifetime
- 2002-06-13 ES ES02748952T patent/ES2281530T3/es not_active Expired - Lifetime
Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US9144631B2 (en) | 2003-01-27 | 2015-09-29 | Benedicte Asius | Ceramic-based injectable implants which are used to fill wrinkles, cutaneous depressions and scars, and preparation method thereof |
DE102011119729A1 (de) | 2011-11-30 | 2013-06-06 | S & V Technologies Ag | Polymerisierbare Farbstoffe und deren Zusammensetzungen für opthalmologische Anwendungen |
WO2013079055A1 (de) | 2011-11-30 | 2013-06-06 | S&V Technologies Ag | Polymerisierbare farbstoffe und deren zusammensetzungen für opthalmologische anwendungen |
Also Published As
Publication number | Publication date |
---|---|
EP1399111A1 (de) | 2004-03-24 |
ES2281530T3 (es) | 2007-10-01 |
FR2825924B1 (fr) | 2007-02-09 |
DE60218157D1 (de) | 2007-03-29 |
WO2002102328A1 (fr) | 2002-12-27 |
PT1399111E (pt) | 2007-04-30 |
FR2825924A1 (fr) | 2002-12-20 |
DE60218157T2 (de) | 2007-10-31 |
ATE353624T1 (de) | 2007-03-15 |
DK1399111T3 (da) | 2007-06-11 |
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